Diabetic Peripheral Neuropathic Pain
Conditions
Brief summary
The purpose of this study is to test the safety and efficacy of study drug LY4065967 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.
Interventions
DRUGLY4065967
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have presence of diabetic peripheral neuropathy, of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument (©University of Michigan) * Have a history and current diagnosis of type 1 or type 2 diabetes mellitus. * Have an HbA1c \<11% and on a stable regimen for treatment of diabetes at least 90 days prior to screening * Have a body mass index at screening of ≤40 kilogram per meter squared (kg/m2)
Exclusion criteria
* Are pregnant or breastfeeding * Have a history of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to diabetic peripheral neuropathic pain (DPNP) * Have lower limb amputation due to diabetes inclusive of great toe (metatarsal bone) * Have serum vitamin B12 ≤200 picogram per milliliter (pg/mL) * Have an abnormal BP (systolic BP \>140 mm Hg and diastolic BP\>90 mm Hg) at screening * Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) | Baseline, Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Brief Pain Inventory-Short Form Modified (BPI-SFM) Total Pain Interference Score | Baseline, Week 8 |
| Change from Baseline in Overall Improvement as Measured by Patient's Global Impression of Change (PGI-C) | Baseline, Week 8 |
| Change from Baseline in Worst Pain Intensity as Measured by NRS | Baseline, Week 8 |
| Change from Baseline in Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) | Baseline, Week 8 |
| Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L) | Baseline, Week 8 |
| Total Amount of Rescue Medication Used Daily During the Treatment Phase | Week 8 |
Countries
Puerto Rico, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed